SpineAlign Medical Inc.

Full article reprinted from Start Up - November/December 2009

Patients with osteoporotic vertebral compression fractures now have another alternative to vertebroplasty or kyphoplasty. The SpineAlign system from SpineAlign Medical Inc. uses a combination of cement and a permanent implant to elevate the vertebral endplates in parallel. In addition, the expandable metal device is composed of nitinol threaded at the end, so that a pedicle screw can be attached and locked into the system for a sturdy construct. Read more...

SpineAlign Medical Inc.

Full article reprinted from Start Up - November/December 2009 

Patients with osteoporotic vertebral compression fractures now have another alternative to vertebroplasty or kyphoplasty, both of which are limited to the application of bone cement to strengthen the vertebra once the height and shape of the vertebral body has been restored. The SpineAlign system from SpineAlign Medical Inc. uses a combination of cement and a permanent implant to elevate the vertebral endplates in parallel. In addition, the expandable, metal device is composed of nickel titanium (nitinol) threaded at the end, so that a pedicle screw can be attached and locked into the system for a sturdy construct.

"The SpineAlign system acts as scaffolding that holds the restored vertebra in place long enough for the cement to then serve as the long-term load bearer," says company founder and current CTO Paul Chirico. The number of patients in the US who are treated for osteoporotic vertebral compression fractures is estimated to be around 150,000 of the 700,000 diagnosed annually, representing a market potential of over $1 billion.

Although Chirico has been impressed with how well vertebroplasty and kyphoplasty have performed over the years, "I just thought there was an opportunity to improve on these techniques and go one step further." Chirico, who has an extensive background in spine and neurosurgery, experimented with several metals before committing to nitinol. Take, for example, stainless steel. "As with a paper clip, you bend stainless steel once and it becomes hard, then bending it a second time it becomes harder, but bending it a third time results in distortion and eventually fractures," he explains. "So I couldn't use stainless steel as an implant that requires collapsing to traverse a small cannula." Chirico also toyed with titanium. "Although titanium is biocompatible and antimagnetic for MRI purposes, it has the same metallic attributes as stainless steel: it tends to fracture over time. But nickel titanium is a memory metal that retains a memory shape while in a collapsed state. Nickel titanium is also vastly underused, despite being tremendously biocompatible."

Gary L. Grenter joined SpineAlign as president and CEO in October 2009 from Spacelabs Healthcare, where he was group president responsible for operations in Europe, the Middle East and Africa. Prior to Spacelabs, Gary was president and CEO for both Kyphon and Bioelectron in the spine area. Paul Chirico served as SpineAlign's president and CEO prior to Grenter's arrival. From 2003 to 2005, Chirico was director of marketing for Micrus Corp., a device manufacturer of coils to treat aneurysms. He was also VP of sales and marketing for Avocet Medical Inc., a developer of the first home-diagnostic kit for patients on the anticoagulant warfarin ( Coumadin), from 1997 to 2000.

SpineAlign Medical has 10 pending patents (none issued) and at least 10 provisional patents. The company shares no royalties/revenues with another entity.

The SpineAlign system is laser cut out of a tube with four struts and is available in both symmetric and asymmetric memory shape to fit the fracture anatomy. The former shape is more elliptical, whereas the latter shape provides a more forward lift to the superior vertebral body endplate.

The minimally invasive procedure is performed under fluoroscopy. Because the implant is shipped in its relaxed (expanded) state, the surgeon must first collapse the device. Following the placement of a 4.7-mm introducer cannula through both pedicles of the vertebral body, a channel in which the implant will reside is created in the cancellous bone (the spongy interior layer of bone) using a small hand drill. The implant is mounted on a rod, then inserted down the cannula and into the cancellous bone, where the collapsed implant is released by turning the handle of the rod and self-expands to the memory shape. The four struts unfold and cut through the cancellous bone in a 10 o'clock, 2 o'clock, 5 o'clock and 7 o'clock arrangement. "Our device does not compress the cancellous bone," Chirico points out. Once it passes the cancellous bone, the device engages the endplates and lifts them gradually.

- Bob Kronemyer

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Companies mentioned in this article:

Alphatec Holdings Inc.

Alphatec Spine Inc.

Spine Wave Inc.

SpineAlign Medical Inc.

Vexim SAS

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